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Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Senft, Goethe University
ClinicalTrials.gov Identifier:
NCT01394692
First received: July 13, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes

July 13, 2011
October 29, 2012
October 2007
July 2010   (final data collection date for primary outcome measure)
Extent of Resection [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Number of patients with contrast-enhancing glioma in whom a complete excision of the tumor according to postoperative high-field MRI within 72 hours is achieved
Extent of Resection [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
The extent of resection following surgery of a contrast-enhancing glioma according to postoperative high-field MRI within 72 hours
Complete list of historical versions of study NCT01394692 on ClinicalTrials.gov Archive Site
  • Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Progression-free survival (radiological and/or clinical progression) at 6 months following surgery
  • Volumetric Assessment [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Volumetric assessment of the extent of resection on early (within 72h) postoperative MRI
  • Neurological Deficit [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Assessment of new postoperative deficits following tumor surgery
Same as current
Not Provided
Not Provided
 
Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery
Resection Control of Primary Brain Tumours Using a Low-Field Intraoperative MRI

Excision to the maximum possible extent marks the first step of glioma surgery. Depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. Multi-centre studies have shown that the presence of residual tumour according to MRI-criteria is a prognostic factor in this incurable condition.

In order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. The intraoperative MRI devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow.

Prospective, high-class evidence data to promote the use of intraoperative MRI in glioma surgery are lacking. To assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative MRI-guidance, we designed this prospective, randomized trial. We hypothesized that the extent of resection that can be achieved using an intraoperative MRI is greater than that of conventional microsurgical tumor resection.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Glioma
  • Procedure: intraoperative MRI-guided tumor resection
    tumor resection with the use of an intraoperative MRI
    Other Name: PoleStar-N20 intraoperative MRI
  • Procedure: standard microsurgery
    microsurgical tumor resection
  • Active Comparator: intraoperative MRI
    tumor resection with intraoperative MRI-guidance
    Intervention: Procedure: intraoperative MRI-guided tumor resection
  • Active Comparator: conventional group
    standard microsurgical tumor resection
    Intervention: Procedure: standard microsurgery
Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol. 2011 Oct;12(11):997-1003. Epub 2011 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
January 2011
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • known or suspected contrast-enhancing glioma (primary and recurrent)
  • location of the tumor permits intended gross-total resection

Exclusion Criteria:

  • tumor location prohibits or questions gross-total resection
  • contraindications to undergo MRI examinations
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01394692
JWG-EK 239/07
No
Christian Senft, Goethe University
Goethe University
Not Provided
Principal Investigator: Christian Senft, M.D. Goethe University
Study Director: Volker Seifert, M.D. Goethe University
Goethe University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP